Elizabeth Orr
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FDA, NIST Join Forces To Improve Manufacturing, Quell Device Shortages
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.
Government Report Outlines Costs, Savings Of Major Regs
The US HHS was responsible for the most major regulations over the last few years of any agency, an OMB report shows.
US FDA Panel To Take Up Lutonix DCB Catheter For Lower-Leg Use Next Month
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.
Device Week, 14 January 2021 – FDA Commissioner News; Spotlight On COVID-19 Enforcement Issues
On this week’s podcast we talk about outgoing US FDA chief Stephen Hahn and the role he wants to play beyond 20 January, as an ex-commissioner. We also discuss the US enforcement landscape around COVID-19-related products and how it’s still taking shape.
Attorneys Expect COVID-19 ‘Enforcement Press’ Centered On PREP Act, Diagnostics
Three attorneys got out their crystal balls to forecast what device industry sectors may come in for enforcement scrutiny related to the COVID-19 pandemic.
With Sun Setting On Trump Admin, HHS Finalizes Regulatory Review Rule
In a change from the draft, the final rule exempts device-specific regulations from scheduled review.